DiabetesNA-PASNCT04836546
Eversense® Non-adjunctive Use Post Approval Study
A study testing Blood glucose meter and Eversense CGM System in people with Diabetes, run by Senseonics, Inc. at 23 sites in United States.
Trial summary
This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Blood glucose meter and Eversense CGM System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 925 participants
- Where
- 23 sitesUnited States
- Study dates
- 13 Apr 2021to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has diabetes
- Subject is ≥18 years of age
- Subject has a smartphone that is internet enabled
- Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
- Subjects is willing and able to provide written signed and dated informed consent
Who cannot join
- Subject is critically ill or hospitalized
- Prior use of CGM defined as:
- No more than 1 week of continuous CGM use in the last 6 months, and
- At least 4 weeks of continuous use of CGM in the last 12 months or 12 weeks total use in the past 3 years.
- Subject has a known contraindication to dexamethasone or dexamethasone acetate
- Subjects requiring intravenous mannitol or mannitol irrigation solutions
- Subject is on dialysis at the time of enrollment
- Female subjects who are pregnant, planning on becoming pregnant or nursing
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Texas Diabetes and Endocrinology
Austin, Texas, 78749
AM Diabetes & Endocrinology
Bartlett, Tennessee, 38133
Southern Maryland Medical Group
Camp Springs, Maryland, 20746
Diabetes and Endocinology Specialists, Inc.
Chesterfield, Missouri, 63017
Southwest Family Medicine Associates
Dallas, Texas, 75235
Metro Detroit Endocrinology
Dearborn, Michigan, 48126
Denver Endocrinology, Diabetes & Thyroid Center
Englewood, Colorado, 80113
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312
Physician's East Endocrinology
Greenville, North Carolina, 27834
CMR of Greater New Haven
Hamden, Connecticut, 06517
Clinical Research Solution Institute
Houston, Texas, 77095
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Endocrine Associates of West Village
Long Island City, New York, 11101
LA Universal Research Center, Inc.
Los Angeles, California, 90057
Tandem Clinical Research
Marrero, Louisiana, 70072
RGV Endocrine Center
McAllen, Texas, 78503
MedCare Research
Miami, Florida, 33165
Miami Lakes Clinical Trials INC
Miami Lakes, Florida, 33014
Green Mountain Research Institute
Rutland, Vermont, 05701
Superior Clinical Research
Smithfield, North Carolina, 27577
Springfield Clinic
Springfield, Illinois, 62702
Chase Medical Research
Waterbury, Connecticut, 06708
About this study
Official title: A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively
This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase.
- Conditions
- Diabetes
- Being tested
- Blood glucose meter, Eversense CGM System
- Keywords
- Type 1 Diabetes, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood glucose meterDevice
First phase: SMBG for 6 months
Eversense CGM SystemDevice
Second phase: CGM for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Self monitoring of blood glucose, then CGM System | Experimental | All participants will first manage their diabetes with SMBG for 6 months followed by managing their diabetes with Eversense CGM system for the next 6 months Receives: Device: Blood glucose meter; Device: Eversense CGM System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events
Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events with SMBG use for 6 months compared to Eversense CGM system used non-adjunctively for 6 months
Measured: First 6 months (phase 1) compared to second 6 months (phase 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start13 Apr 2021
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 925 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Senseonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836546
- Sponsor's protocol ID
- CTP-0039
- Acronym
- NA-PAS
- Status last verified
- Aug 2025
- First submitted
- 30 Mar 2021
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively
- ClinicalTrials.gov ID
- NCT04836546
- Acronym / sponsor ID
- NA-PAS / CTP-0039
- Conditions
- Diabetes
- Keywords
- Type 1 Diabetes, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 925 participants (estimated)
- Lead sponsor
- Senseonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self monitoring of blood glucose, then CGM System | Experimental | Device: Blood glucose meter, Device: Eversense CGM SystemAll participants will first manage their diabetes with SMBG for 6 months followed by managing their diabetes with Eversense CGM system for the next 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has diabetes
- Subject is ≥18 years of age
- Subject has a smartphone that is internet enabled
- Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
- Subjects is willing and able to provide written signed and dated informed consent
Key exclusion criteria (8 listed)
- Subject is critically ill or hospitalized
- Prior use of CGM defined as:
- Subject has a known contraindication to dexamethasone or dexamethasone acetate
- Subjects requiring intravenous mannitol or mannitol irrigation solutions
- Subject is on dialysis at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood glucose meterFirst phase: SMBG for 6 months | Device | Self monitoring of blood glucose, then CGM System |
| Eversense CGM SystemSecond phase: CGM for 6 months | Device | Self monitoring of blood glucose, then CGM System |
Primary outcome
Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events
Time frame: First 6 months (phase 1) compared to second 6 months (phase 2)
Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events with SMBG use for 6 months compared to Eversense CGM system used non-adjunctively for 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood glucose meter and Eversense CGM System in people with Diabetes, run by Senseonics, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events (time frame: First 6 months (phase 1) compared to second 6 months (phase 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.